Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching
NCT ID: NCT06884813
Last Updated: 2025-03-24
Study Results
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Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-03-10
2026-08-01
Brief Summary
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The null hypotheses will be:
1. Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching.
2. Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
3. Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.
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Detailed Description
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This study will explore the ability of Omnichroma restorations to shade match tooth structure after bleaching. Patients visiting the JUST dental clinics who have at least two anterior restorations (one Omnichroma restoration and one multi-shade nanohybrid composite restoration) will be recruited for this study. The calculated sample size for the study is 240 teeth.
The shade and the L\*a\*b\* scores will be recorded using spectrophotometer prior to bleaching and after bleaching. Two blinded, calibrated dentists will independently evaluate the resulting shade outcomes and assess the degree of color match between the restorations and the adjacent teeth after bleaching. This assessment will be categorized as either match or no match. The patient's satisfaction will also be recorded two weeks after bleaching.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group (Conventional RBC)
In office bleaching for teeth restored using conventional multishade nanohybrid resin based composite (RBC).
Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System
Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
Test group (RBC with CAP)
In office bleaching for teeth restored using Omnichroma (single shade) composite with color adjustment postential (CAP).
Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System
Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
Interventions
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Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System
Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System
Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who are willing to sign an informed consent form.
3. Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
4. Patients aged 18 years or older.
5. Patients with good oral hygiene
6. Patients with vital teeth.
7. Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment.
Exclusion Criteria
2. Patients with non-vital teeth restored with composite fillings.
3. Patients with severe tooth discoloration.
4. Patients with fluorosis or tetracycline staining.
5. Heavy smokers.
6. Pregnant or nursing women.
7. Patients undergoing orthodontic treatment.
8. Patients with enamel or dentin deformations.
18 Years
ALL
Yes
Sponsors
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King Abdullah University Hospital
OTHER
Responsible Party
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Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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Central Contacts
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Facility Contacts
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References
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Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25.
Hafez R, Ahmed D, Yousry M, El-Badrawy W, El-Mowafy O. Effect of in-office bleaching on color and surface roughness of composite restoratives. Eur J Dent. 2010 Apr;4(2):118-27.
Forabosco E, Consolo U, Mazzitelli C, Kaleci S, Generali L, Checchi V. Effect of bleaching on the color match of single-shade resin composites. J Oral Sci. 2023 Oct 1;65(4):232-236. doi: 10.2334/josnusd.23-0159. Epub 2023 Aug 3.
AlHabdan A, AlShamrani A, AlHumaidan R, AlFehaid A, Eisa S. Color Matching of Universal Shade Resin-Based Composite with Natural Teeth and Its Stability before and after In-Office Bleaching. Int J Biomater. 2022 Oct 26;2022:8420890. doi: 10.1155/2022/8420890. eCollection 2022.
Other Identifiers
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20250033
Identifier Type: -
Identifier Source: org_study_id
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